Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Development of noninvasive MRI methods to measure kidney disease using MR elastography.
研究概览
简要总结
The investigators plan a prospective cross-sectional study of pediatric and adult healthy volunteers and patients with chronic kidney disease that will correlate a variety of quantitative MRI biomarkers with severity of renal insufficiency and available histopathology. Over 3 years, the investigators will recruit approximately 20 healthy volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with renal transplant kidneys. The investigators also plan to assess the effect of inflammation on the quantitative MRI biomarkers by recruiting approximately 20 additional patients with active lupus nephritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following criteria will be eligible for the study:
- •≥ 10 and ≤ 25 years of age and;
- •Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
- •Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
- •Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
- •Healthy Controls
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
- •Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
- •Inability to undergo MRI without sedation/anesthesia.
- •Non-English Speaking
研究组 & 干预措施
Healthy Volunteers
20 healthy volunteers will be recruited and will receive a kidney MRI and the same blood and urine labs that are collected for the other arms. Results will be compared to the disease groups.
干预措施: Kidney MRI (Diagnostic Test)
Kidney Transplant
20 subjects that have received a kidney transplant that have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.
干预措施: Kidney MRI (Diagnostic Test)
Stage 2-5 CKD
20 subjects that have been diagnosed with stage 2-5 CKD and have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.
干预措施: Kidney MRI (Diagnostic Test)
Lupus nephritis
20 subjects that have that have active lupus nephritis and have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.
Subjects that are post-lupus treatment will receive an additional MRI at the time of the next biopsy.
干预措施: Kidney MRI (Diagnostic Test)
结局指标
主要结局
Development of noninvasive MRI methods to measure kidney disease using MR elastography.
时间窗: 3 years
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
时间窗: 3 years
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
时间窗: 3 years
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
时间窗: 3 years
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
时间窗: 3 years
Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.
时间窗: 3 years
Intra-voxel incoherent motion and diffusion tensor imagining will be measured.
次要结局
未报告次要终点